St. Louis, Missouri 63110

  • New Imaging Techniques in Colonoscopy

Purpose:

In this study the investigators hypothesize that High Definition White Light colonoscopy and narrow band imaging (NBI) will detect a higher number of adenomas compared to standard definition white light colonoscopy. NBI will have a higher accuracy in predicting polyp histology compared to high definition colonoscopy and standard colonoscopy. Specific Aim 1 - To compare the prevalence of adenomas detected by standard colonoscopy, high-definition white light colonoscopy and NBI. Specific Aim 2 - To compare the number of adenoma detected per subject by standard colonoscopy, high-definition white light colonoscopy and NBI. Specific Aim 3 - To compare the accuracy of predicting polyp histology between standard colonoscopy, high-definition white light colonoscopy and NBI by evaluating the surface mucosal and vascular patterns during the procedure. Specific Aim 4 - To determine the inter-observer agreement between investigators for the recognition of various polyp patterns


Study summary:

This study is a multi-center randomized controlled trial that will be conducted at the Kansas City VA Medical Center, Kansas City, MO and The Barnes Jewish Hospital, St Louis, MO. Patients referred for screening and surveillance colonoscopy will be enrolled. They will be randomized to one of the following three groups: standard white light colonoscopy, high-definition white light colonoscopy or NBI. All colonoscopies will be performed at the Kansas City VA Medical Center and The Barnes Jewish Hospital, St Louis, MO. Moderate sedation will be administered for the procedure with intravenous midazolam, demerol or fentanyl and Propofol. In patients randomized to the NBI arm, the colonoscope will be inserted to the cecum under white light and will switch to NBI mode at the time of withdrawal. After cecal intubation, the colonic mucosa will be carefully visualized during withdrawal of the scope with one of the three imaging modalities to which the patient has been randomized. No effort will be made to look for polyps during the insertion of the colonoscope. All polyps detected will be documented for their size, morphology (Polypoid: sessile, pedunculated or Non polypoid: superficially elevated, completely flat, depressed), and location. The surface of the polyp will be assessed during the procedure and the histology will be predicted real time by evaluating the surface mucosal and vascular patterns. The patterns would be classified into one of the four patterns described in our pilot study (tubular and gyrus patterns will be combined to tubulogyrus pattern). Any other patterns detected would be described and kept in the miscellaneous category. If a pattern is not identified on a polyp with either white light or NBI, it will be recorded as such and no attempts will be made to predict histology. Photo documentation of the surface patterns of the polyps will be performed. Polyps will then be removed either with a biopsy forcep or snare and sent for histopathological evaluation. Each polyp removed will have one or more corresponding picture of its surface patterns and these will be labeled accordingly. The total time spent in inspecting the colonic mucosa (excluding the time spent in removal of polyps or clearing the colon of liquid and solid debris) will be measured with a stop watch. Representative images of the various polyp patterns will be reviewed, discussed and standardized amongst all the investigators at both sites. In addition, images of all the polyp patterns will be printed and posted in the endoscopy suites at both hospitals. The bowel preparation will be evaluated and graded as follow: Excellent (score=1) - >90% mucosa seen, mostly liquid colonic contents, minimal suctioning needed for adequate visualization. Good (score=2) - >90% of mucosa seen, mostly liquid colonic contents, significant suctioning needed for adequate visualization Fair (score=3) - > 90% mucosa seen, mixture of liquid and semisolid colonic contents, could be suctioned and/or washed Inadequate (score=4) - <90% mucosa seen, mixture of semisolid ands solid colonic contents, which could not be suctioned or washed Patients with "Inadequate" (score = 4) bowel prep will be excluded.


Criteria:

Inclusion criteria: - referral for screening or surveillance colonoscopy - the ability to provide informed consent Exclusion criteria: - prior surgical resection of any portion of colon - prior history of colon cancer - history of inflammatory bowel disease - use of anti-platelet agents or anticoagulants that precludes removal of polyps during the procedure - poor general condition or any other reason to avoid prolonged procedure time - history of polyposis syndrome or HNPCC - inability to give informed consent. - Inadequate bowel preparation


Study is Available At:


Original ID:

AR0003


NCT ID:

NCT00614770


Secondary ID:

AR0003


Study Acronym:


Brief Title:

Narrow Band Imaging Colon Polyp Study


Official Title:

A Multicenter, Prospective, Randomized Controlled Trial for the Detection of Colon Polyps and Predicting Histology


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Kansas City Veteran Affairs Medical Center


Oversight Authority:

  • United States: Federal Government
  • Human Subjects Committee, Kansas City VA Medical Center, Kansas City, MO, USA:


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

630


Enrollment Type:

Actual


Overall Contact Information

Official Name:Amit Rastogi, MD
Principal Investigator
Kansas City VA Medical Center

Study Dates

Start Date:February 2008
Completion Date:December 2009
Completion Type:Actual
Primary Completion Date:November 2009
Primary Completion Type:Actual
Verification Date:June 2010
Last Changed Date:June 16, 2010
First Received Date:January 31, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Secondary outcome will be number of adenomas detected per subject in the three arms, the sensitivity, specificity, and accuracy of predicting polyp histology real time by the three imaging modalities.
Time Frame:2 years
Safety Issues:False
Outcome Type:Primary Outcome
Measure:The prevalence of adenomas in the three arms of the study.
Time Frame:2 years
Safety Issues:False
Description:Number of subjects with adenomas in the three arms of the study

Study Interventions

Intervention Type:Procedure
Name:standard of care colonoscopy
Description:Standard White Light Colonoscopy one exam per patient
Arm Name:1
Intervention Type:Procedure
Name:colonoscopy
Description:Narrow Band Imaging Colonoscopy one exam per patient
Arm Name:3
Intervention Type:Procedure
Name:standard of care colonoscopy
Description:High Definition White Light Colonoscopy one exam per patient
Arm Name:2

Study Arms

Study Arm Type:Experimental
Arm Name:3
Description:Narrow Band Imaging Colonoscopy
Study Arm Type:Experimental
Arm Name:2
Description:High Definition White Light Colonoscopy
Study Arm Type:Experimental
Arm Name:1
Description:Standard White Light Colonoscopy

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:Kansas City Veteran Affairs Medical Center
Agency Class:Other
Agency Type:Collaborator
Agency Name:American Society for Gastrointestinal Endoscopy

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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